Engaging Informal Health Care Providers on Case Detection and Treatment Initiation Rates for TB and HIV in Rural Malawi (Triage Plus) (Triage)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The intervention consisted of training non-paid informal healthcare providers (such as store-keepers) in TB and HIV disease recognition, sputum specimen collection, referral to the public health system, and raising community awareness. Front line public health personnel and community leaders were sensitised to support the intervention.

Condition or disease	Intervention/treatment	Phase
Tuberculosis; HIV	Behavioral: Early intervention; Behavioral: Delayed intervention	Not Applicable

Detailed Description:

A phased, matched, parallel cluster design was used to randomise three clusters (average population size per cluster = 200,714) to the Early intervention arm (received the intervention early in the first 12 months) and an equal number to the Delayed intervention arm (average population size per cluster = 209,564) which received the intervention after one year. Data for impact evaluation were obtained from routine patient registers in all the health facilities and patients were blindly allocated to the respective clusters based on residential address. Treatment initiation rates (expressed as incidence rate ratios) for TB and Anti Retroviral Therapy (ART) over the 12 months period were the primary outcome measures for each of the studied conditions. Poisson regression models with robust standard errors were used to assess the effectiveness of the intervention.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	200000 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Health Services Research
Official Title:	Engaging Informal Health Care Providers on Case Detection and Treatment Initiation Rates for TB and HIV in Rural Malawi (Triage Plus): a Cluster Randomised Health System Intervention Trial
Study Start Date :	January 2009
Actual Primary Completion Date :	December 2011
Actual Study Completion Date :	December 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Early intervention; Early intervention arm engaging informal providers Received the intervention early in the first 12 months	Behavioral: Early intervention; Training non-paid informal healthcare providers (such as store-keepers) in TB and HIV disease recognition, sputum specimen collection, referral to the public health system, and raising community awareness. Front line public health personnel and community leaders were sensitised to support the intervention; Other Names: Early intervention arm engaging informal providers; Received the intervention early in the first 12 months
Active Comparator: Delayed intervention; Delayed intervention arm, engaging informal providers Received the intervention after one year	Behavioral: Delayed intervention; Delayed intervention arm, engaging informal providers Received the intervention after one year

Outcome Measures

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Primary Outcome Measures :

1. TB and HIV treatment initiation [ Time Frame: 2 years ]
   the cumulative counts of patients initiating TB and HIV treatment per 10,000 adults aged 12 years and above each month over the intervention period

Secondary Outcome Measures :

1. TB and HIV diagnostic uptake rates. [ Time Frame: 2 years ]

Eligibility Criteria

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Ages Eligible for Study:	16 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• People accessing informal providers with possible TB or HIV

Exclusion Criteria:

• children
• people already with a diagnosis of TB or HIV

Contacts and Locations

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Locations

Malawi
REACH Trust
Lilongwe, Malawi

Sponsors and Collaborators

Liverpool School of Tropical Medicine

Research for Equity And Community Health REACH Trust

Ministry of Health and Population, Malawi

LHL International Tuberculosis Foundation

University of Warwick

Investigators

Principal Investigator:	Rachael Thomson, MSc	LSTM

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bello G, Faragher B, Sanudi L, Namakhoma I, Banda H, Malmborg R, Thomson R, Squire SB. The effect of engaging unpaid informal providers on case detection and treatment initiation rates for TB and HIV in rural Malawi (Triage Plus): A cluster randomised health system intervention trial. PLoS One. 2017 Sep 6;12(9):e0183312. doi: 10.1371/journal.pone.0183312. eCollection 2017.

Responsible Party:	Liverpool School of Tropical Medicine
ClinicalTrials.gov Identifier:	NCT02127983 History of Changes
Other Study ID Numbers:	TriagePlus
First Posted:	May 1, 2014
Last Update Posted:	May 1, 2014
Last Verified:	December 2012

Keywords provided by Liverpool School of Tropical Medicine:

TB, HIV, case finding, access, informal providers

Additional relevant MeSH terms:

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections